BENCH

• Research type

  Research Study

• Full title

  Breath analysis using an Electronic Nose in Cirrhosis with portal Hypertension (BENCH study)

• IRAS ID

  250512

• Contact name

  Peter Hayes

• Contact email

  p.hayes@ed.ac.uk

• Sponsor organisation

  University of Edinburgh

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Application of electronic nose (eNose) in analysis of exhaled breath has been shown to be a promising tool for evaluating disease and has shown potential for distinguishing between healthy subject and patients with chronic liver disease. Sensitive electronic sensors detect molecules in breath and generate signals. Complex algorithms and analytical technicals allow pattern recognition of
  breath samples from different subjects. Data generated from the electronic nose will not be used in the pursuit of a CE mark, however none of the data will be used for commercial purposes. This is potentially an easy-to-perform, cheap, non-invasive and complimentary assessment of chronic liver disease and perhaps more specifically, the complications of such including portal hypertension. One important complication associated with portal hypertension is the development of oesophageal varices as they can bleed and are associated with a 20% risk of death. This diagnosis is made by means of an endoscopy test which can be difficult to tolerate and painful for some patients as well as being associated with clinical complications. eNOSE may be an alternative, much more tolerable and safer test.

  The main objectives are to 1. Establish whether there is a specific breath-signature in patients with cirrhotic liver disease who have developed portal hypertension.
  2. Establish whether there is a specific breath-signature in patients with cirrhotic liver disease corresponding to the stage of liver disease as assessed by clinical, biochemical and radiological parameters.

  The Royal Infirmary of Edinburgh will be the only site recruiting for this study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  18/SC/0455

• Date of REC Opinion

  22 Aug 2018

• REC opinion

  Favourable Opinion